title: Photodynamic therapy with 3-(1'-hexyloxyethyl) pyropheophorbide a for cancer of the oral cavity.
abstract: OBJECTIVE
  The primary objective was to evaluate safety of 3-(1'-hexyloxyethyl)pyropheophorbide-a (HPPH) photodynamic therapy (HPPH-PDT) for dysplasia and early squamous cell carcinoma of the head and neck (HNSCC). Secondary objectives were the assessment of treatment response and reporters for an effective PDT reaction.
  
  
  METHODS
  Patients with histologically proven oral dysplasia, carcinoma in situ, or early-stage HNSCC were enrolled in two sequentially conducted dose escalation studies with an expanded cohort at the highest dose level. These studies used an HPPH dose of 4 mg/m(2) and light doses from 50 to 140 J/cm(2). Pathologic tumor responses were assessed at 3 months. Clinical follow up range was 5 to 40 months. PDT induced cross-linking of STAT3 were assessed as potential indicators of PDT effective reaction.
  
  
  RESULTS
  Forty patients received HPPH-PDT. Common adverse events were pain and treatment site edema. Biopsy proven complete response rates were 46% for dysplasia and carcinoma in situ and 82% for squamous cell carcinomas (SCC) lesions at 140 J/cm(2). The responses in the carcinoma in situ/dysplasia cohort are not durable. The PDT-induced STAT3 cross-links is significantly higher (P = 0.0033) in SCC than in carcinoma in situ/dysplasia for all light doses.
  
  
  CONCLUSIONS
  HPPH-PDT is safe for the treatment of carcinoma in situ/dysplasia and early-stage cancer of the oral cavity. Early-stage oral HNSCC seems to respond better to HPPH-PDT in comparison with premalignant lesions. The degree of STAT3 cross-linking is a significant reporter to evaluate HPPH-PDT-mediated photoreaction.
authors.affiliation: Authors' Affiliations: Photodynamic Therapy Center at the Department of Cell Stress Biology, Departments of Head and Neck Surgery, Molecular and Cellular Biology, Biostatistics and Bioinformatics, Dentistry, and Pathology, Roswell Park Cancer Institute (RPCI), Buffalo, New York.
authors.forename: Nestor
authors.initials: N
authors.lastname: Rigual
authors.forename: Gal
authors.initials: G
authors.lastname: Shafirstein
authors.forename: Michele T
authors.initials: MT
authors.lastname: Cooper
authors.forename: Heinz
authors.initials: H
authors.lastname: Baumann
authors.forename: David A
authors.initials: DA
authors.lastname: Bellnier
authors.forename: Ulas
authors.initials: U
authors.lastname: Sunar
authors.forename: Erin C
authors.initials: EC
authors.lastname: Tracy
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Rohrbach
authors.forename: Gregory
authors.initials: G
authors.lastname: Wilding
authors.forename: Wei
authors.initials: W
authors.lastname: Tan
authors.forename: Maureen
authors.initials: M
authors.lastname: Sullivan
authors.forename: Mihai
authors.initials: M
authors.lastname: Merzianu
authors.forename: Barbara W
authors.initials: BW
authors.lastname: Henderson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D002734:Chlorophyll / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D050796:STAT3 Transcription Factor / Q000378:metabolism; D014018:Tissue Distribution; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; D050796:STAT3 Transcription Factor; C494086:STAT3 protein, human; D002734:Chlorophyll; C083998:2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a